More extensive Medical Device Services at Biocodex – Services tailored to the requirements of the European MDR Regulation
Medical Device Services draw on Biocodex’s long and extensive experience and leading expertise in pharmaceuticals and medical services. Currently, Biocodex provides expert services to over 130 pharmaceutical companies in the Nordic and Baltic countries.
Biocodex´s Medical Device Services include a full service portfolio for the needs of healthcare units, manufacturers, subcontractors, importers, distributors, and sales and marketing organizations. The services enable large-scale Complaint processing, proactive Post-Market Surveillance and Clinical Evaluation functions. ”On the other hand, we can also help a small operator to, for example, build a quality system tailored to their needs says Jonas Hinkkanen, Head of Regulatory Affairs at Biocodex.
Jonas Hinkkanen joined Biocodex earlier this year. He has more than 15 years of experience in quality and regulatory affairs. He is also an expert in medical devices, focusing on designing, development and validation. Over the years, Jonas has acted in a leading role in various medical device companies. “In Biocodex, I was interested in a unique business model that combines manufacturers, sales, marketing organizations and service providers all in one company,” says Jonas Hinkkanen.
The European MDR Regulation coming into force in May 2020 will mark the biggest change in the whole medical device sector since the previous directive. The EU MDR will touch and oblige not only manufacturers but also importers, distributors, healthcare units and authorized representatives. The Regulation, when it enters into force, will harmonize national differences in the legislation on medical devices.
”Existing and operational service models and concepts have been expanded and tailored to meet the needs of the Medical Device industry, especially with respect to EU MDR obligations”, says Jonas Hinkkanen.
The need for service will grow dramatically in the future, not least for regulatory reasons but also because of the desire of operators to focus on their core competencies, such as product design, sales and marketing. However, the EU MDR requires, for example, proactive post-market monitoring by manufacturers as well as ongoing clinical evaluation for each product or family of products.
”Similarly, importers and distributors are required to have, at the very least, a quality system and a quality system in place in the healthcare industry. Biocodex is already capable of providing services in all of these new areas”, states Jonas Hinkkanen.
Medical Device Services at Biocodex
At Biocodex, we are dedicated to providing our clients with the very best pharmaceutical and medical consultant services. In the rapidly evolving pharmaceutical industry, we help our clients overcome the challenges they may have ahead. Read more about Biocodex´s Medical Device Services >